Biomarker · Gene alteration

TP53 mutation

Somatic TP53 mutations detected by sequencing of tumor tissue or marrow; used mainly as a prognostic and risk-stratification marker across solid and hematologic malignancies.

CI-BIO-00000034TP53 graph →NCIt C118396

Also calledTP53-mutated · p53 mutation · TP53-mutant

Derived

Associated cancers (26)

Cancers mapped in ACCEPTED CIViC predictive, prognostic or diagnostic items whose variant (molecular markers) or gene (gene-level markers) is in this biomarker's scope. Counts by type and native level; each row links to the cancer's evidence tab.

Computedrule biomarker-links-v1

Cancer	Items	Predictive	Prognostic	Diagnostic	Levels A / B / C / D / E
Malignant Neoplasm	21	21	—	—	0 / 1 / 0 / 19 / 1
Malignant Breast Neoplasm	15	5	10	—	0 / 11 / 1 / 2 / 1
Chronic Lymphocytic Leukemia	7	1	6	—	1 / 6 / 0 / 0 / 0
Malignant Ovarian Neoplasm	7	4	3	—	0 / 5 / 2 / 0 / 0
Gastric Carcinoma

Derived

Drugs with predictive evidence (24)

Therapies named in in-scope PREDICTIVE CIViC items, plus targets of PREDICTS_RESPONSE_TO knowledge edges from in-scope variants. Sensitivity and resistance are counted separately and never merged into a verdict.

Computedrule biomarker-links-v1

Drug	CIViC items	Sensitivity	Resistance	Best level	Edges (S / R)	Cancer context
MDM2 Inhibitor AMGMDS3	17	1	16	D	1 / 16	Malignant Neoplasm
CisplatinSmall Molecule	9	4	5	B	3 / 5	Gastric Carcinoma, Malignant Gastric Neoplasm,

Curated evidence

Predictive evidence items (52)

ACCEPTED CIViC predictive items in scope, grouped by molecular profile and therapy with native level, direction and cancer context. 50 per page.

civicCuratedShowing 1–50 of 52 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
TP53 Mutation8
Alemtuzumab

Regulatory

Approvals mentioning the linked drugs (444)

Approval records of the derived drug set, plus records whose indication text names this biomarker. Each record names its authority, jurisdiction, indication text and status — a drug approved in one jurisdiction for one indication is not 'approved' in general, and an approval listed here is not necessarily restricted to this biomarker.

Computedrule biomarker-links-v1

health-canada-dpd

Clinical trials

Active trials (1,109)

Trials with an active ClinicalTrials.gov status, an intervention mapped to a derived drug and a condition mapped to an associated cancer. 558 recruiting · 287 active phase 3 · 5,092 in any status. Most recently updated first, 50 per page.

Computedrule biomarker-links-v1

clinicaltrialsPublishedShowing 1–50 of 1,109 active studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT00092222	Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity	active not recruiting	Phase 2

Literature

Linked publications (58)

Publications linked to the scope gene(s) through PubMed entity edges; 25 per page, newest first.

pubmedPublishedShowing 51–58 of 58 publications · bibliographic data as recorded by PubMed; abstracts are not reproduced.

Cancer-associated p53 tetramerization domain mutants: quantitative analysis reveals a low threshold for tumor suppressor inactivation.
· J Biol Chem · 2011 · PMID 20978130 · validated civic_curation pubmed
Tumour p53 mutations exhibit promoter selective dominance over wild type p53.
· Oncogene · 2002 · PMID 11896595 · validated civic_curation pubmed
Dominant-negative mutations of the tumor suppressor p53 relating to early onset of glioblastoma multiforme.
· Cancer Res · 1999 · PMID 10519380 · validated civic_curation pubmed
Dominant-negative features of mutant TP53 in germline carriers have limited impact on cancer outcomes.
· Mol Cancer Res · 2011 · PMID 21343334 · validated

TP53 Wildtype6
Chemotherapy	Esophageal Carcinoma	Predictive	B	Supports Sensitivity Response	3	accepted	EID906 Patients with p53 wild type (as defined by low expression and/or wild-type tp53 gene) had a higher response rate to chemotherapy-based treatment (total major response [MR]: risk ratio [RR] = 1.09, 95 … (full text at CIViC) PMID 23515910 · Zhang et al., 2013 · Open in CIViC	civic
RG7112	Leukemia	Predictive	B	Supports Sensitivity Response	3	accepted	EID2965 Phase I Trial of RG7112 in 116 heavily pretreated patients with AML, ALL, CML, CLL, sCLL demonstrated sustained clinical improvement and induction of TP53 target genes in subset of patients with wild … (full text at CIViC) PMID 26459177 · Andreeff et al., 2016 · Open in CIViC	civic
Adjuvant Chemotherapy	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	accepted	EID1149 Pooled analysis of TP53 mutations (exons 5-8) from 4 randomized trials (IALT, JBR10, CALGB-9633 and ANITA, 1209 patients, median follow-up 5.5 years) of platinum-based adjuvant chemotherapy (ACT) vers… (full text at CIViC) PMID 26899019 · Ma et al., 2016 · Open in CIViC	civic
Capecitabine + Cetuximab + OxaliplatinCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	accepted	EID875 In this retrospective biomarker analysis of the EXPERT-C trial, patients with TP53 wild-type status had a statistically significant better progression free survival (PFS) (89.3% vs 65.0% at 5 years; h… (full text at CIViC) PMID 24957073 · Sclafani et al., 2014 · Open in CIViC	civic
MDM2 Inhibitor AMGMDS3	Malignant NeoplasmALIAS	Predictive	D	Supports Sensitivity Response	4	accepted	EID2964 MDM2 Inhibitor screen in a panel of 260 cancer cell lines with well characterized TP53 status shows that only cancer cell lines with unaltered TP53 may be sensitive to MDM2 Inhibitor. PMID 25730903 · Saiki et al., 2015 · Open in CIViC	civic
Rebemadlin	Malignant NeoplasmALIAS	Predictive	D	Supports Sensitivity Response	4	accepted	EID2963 MDM2 Inhibitor Nutlin-3a induced senescence in presence of functional TP53 in murine primary fibroblasts, oncogenically transformed fibroblasts, and fibrosarcoma cell lines. Cells lacking functional T… (full text at CIViC) PMID 17671205 · Efeyan et al., 2007 · Open in CIViC	civic

TP53 R273C2
Cisplatin + Etoposide + MitomycinCombination	Gastric CarcinomaALIAS	Predictive	C	Does Not Support Sensitivity Response	3	accepted	EID2292 A female patient taking part in a 25 patient gastric cancer trial was diagnosed at age 46, and received preoperative high dose chemotherapy (HDCT). Japanese Society for Gastric Cancer Response Score w… (full text at CIViC) PMID 14514923 · Bataille et al., 2003 · Open in CIViC	civic
MDM2 Inhibitor AMGMDS3	Malignant NeoplasmALIAS	Predictive	D	Supports Resistance	4	accepted	EID4881 Subset of 58 cancer cell lines with unaltered TP53 is sensitive to MDM2 Inhibitor AMGMDS3. None of 115 cancer cell lines with TP53 mutation and absence of WT allele are sensitive to MDM2 Inhibitor. TP… (full text at CIViC) PMID 25730903 · Saiki et al., 2015 · Open in CIViC	civic

TP53 Y220C2
Cisplatin + Etoposide + MitomycinCombination	Gastric CarcinomaALIAS	Predictive	C	Supports Sensitivity Response	3	accepted	EID2306 A male patient taking part in a 25 patient gastric cancer trial was diagnosed at age 50, harbored a TP53 mutation and received preoperative high dose chemotherapy (HDCT). Japanese Society for Gastric … (full text at CIViC) PMID 14514923 · Bataille et al., 2003 · Open in CIViC	civic
MDM2 Inhibitor AMGMDS3	Malignant NeoplasmALIAS	Predictive	D	Supports Resistance	4	accepted	EID4884 Subset of 58 cancer cell lines with unaltered TP53 is sensitive to MDM2 Inhibitor AMGMDS3. None of 115 cancer cell lines with TP53 mutation and absence of WT allele are sensitive to MDM2 Inhibitor. TP… (full text at CIViC) PMID 25730903 · Saiki et al., 2015 · Open in CIViC	civic

TP53 R175H4
EAP Protocol	Gastric CarcinomaALIAS	Predictive	C	Supports Sensitivity Response	—	accepted	EID2310 In a study of 25 patients with advanced gastric cancer, mutations in TP53 were identified in 32% of primary tumors. TP53 mutations were associated with an improved response to preoperative treatment o… (full text at CIViC) PMID 14514923 · Bataille et al., 2003 · Open in CIViC	civic
Doxorubicin	Malignant Breast Neoplasm	Predictive	D	Supports Sensitivity Response	3	accepted	EID319 Breast tumors in a mouse model with R172H mutation (homologous to human R175H) are more responsive to doxorubicin than breast tumors with wild type TP53. PMID 22698404 · Jackson et al., 2012 · Open in CIViC	civic
MDM2 Inhibitor AMGMDS3	Malignant NeoplasmALIAS	Predictive	D	Supports Resistance	3	accepted	EID4880 Subset of 58 cancer cell lines with unaltered TP53 is sensitive to MDM2 inhibitor AMGMDS3. None of 115 cancer cell lines with TP53 mutation and absence of WT allele are sensitive to MDM2 inhibitor. TP… (full text at CIViC) PMID 25730903 · Saiki et al., 2015 · Open in CIViC	civic
〃	Malignant NeoplasmALIAS	Predictive	D	Supports Resistance	3	accepted	EID10074 Subset of 58 cancer cell lines with unaltered TP53 is sensitive to MDM2 inhibitor AMGMDS3. None of 115 cancer cell lines with TP53 mutation and absence of WT allele are sensitive to MDM2 inhibitor. TP… (full text at CIViC) PMID 25730903 · Saiki et al., 2015 · Open in CIViC	civic

TP53 Deleterious Mutation4
RG7112	Leukemia	Predictive	B	Supports Resistance	3	accepted	EID2966 Phase I Trial of MDM2 inhibitor RG7112 in 116 patients with AML, ALL, CML, CLL, sCLL demonstrated sustained clinical improvement and induction of TP53 target genes in subset of patients with wild type… (full text at CIViC) PMID 26459177 · Andreeff et al., 2016 · Open in CIViC	civic
Adjuvant Chemotherapy	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Does Not Support Sensitivity Response	2	accepted	EID1148 Pooled analysis of TP53 mutations (exons 5-8) from 4 randomized trials (IALT, JBR10, CALGB-9633 and ANITA) of platinum-based adjuvant chemotherapy (ACT) versus observation (OBS). Patients with TP53wt … (full text at CIViC) PMID 26899019 · Ma et al., 2016 · Open in CIViC	civic
MDM2 Inhibitor AMGMDS3	Malignant NeoplasmALIAS	Predictive	D	Supports Resistance	4	accepted	EID2967 MDM2 Inhibitor screen in a panel of 260 cancer cell lines with well characterized TP53 status shows that only cancer cell lines with unaltered TP53 may be sensitive to MDM2 Inhibitor AMGMDS3, while th… (full text at CIViC) PMID 25730903 · Saiki et al., 2015 · Open in CIViC	civic
Rebemadlin	Malignant NeoplasmALIAS	Predictive	D	Supports Resistance	4	accepted	EID2968 MDM2 Inhibitor Nutlin-3a induced senescence in presence of functional TP53 in murine primary fibroblasts, oncogenically transformed fibroblasts, and fibrosarcoma cell lines. TP53 mutant cells lacking … (full text at CIViC) PMID 17671205 · Efeyan et al., 2007 · Open in CIViC	civic

TP53 Overexpression2
Cisplatin + Etoposide + MitomycinCombination	Malignant Gastric Neoplasm	Predictive	B	Supports Sensitivity Response	4	accepted	EID2799 In a Phase II trial of 25 patients with metastaic gastric cancer, patients received preoperative high dose chemotherapy (HDCT) consisting of etoposide, cisplatin and mitomycin. Patients with greater t… (full text at CIViC) PMID 14514923 · Bataille et al., 2003 · Open in CIViC	civic
Carboplatin + CisplatinSubstitutes	Malignant Ovarian Neoplasm	Predictive	B	Supports Resistance	3	accepted	EID3013 In a study involving patients with invasive ovarian carcinoma who had undergone surgery, a subset of 73 patients were classified via response to platinum-based chemotherapy as sensitive or resistant/r… (full text at CIViC) PMID 11595686 · Reles et al., 2001 · Open in CIViC	civic

Drug	Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
Pazopanib	CA Health Canada	—	Marketed in Canada as SANDOZ PAZOPANIB (DIN 02521180) under ATC L01EX03 PAZOPANIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Oct 26, 2023	—	health-canada-dpd
Pazopanib	CA Health Canada	—	Marketed in Canada as VOTRIENT (DIN 02352311) under ATC L01EX03 PAZOPANIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Jul 8, 2020	—	health-canada-dpd
Selumetinib	CA Health Canada	—	Marketed in Canada as KOSELUGO (DIN 02530139) under ATC L01EE04 SELUMETINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jan 3, 2023	health-canada-dpd
Selumetinib	CA Health Canada	—	Marketed in Canada as KOSELUGO (DIN 02530147) under ATC L01EE04 SELUMETINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jan 3, 2023	health-canada-dpd
Selumetinib	CA Health Canada	—	Marketed in Canada as KOSELUGO GRANULES (DIN 02569744) under ATC L01EE04 SELUMETINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Selumetinib	CA Health Canada	—	Marketed in Canada as KOSELUGO GRANULES (DIN 02569736) under ATC L01EE04 SELUMETINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as TAMOXIFENE - 10 (DIN 02296721) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Jul 27, 2011	Oct 29, 2007	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as TAMOXIFENE - 20 (DIN 02296748) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Jul 27, 2011	Oct 29, 2007	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as TAMOXIFEN (DIN 02237596) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Oct 25, 2016	Sep 28, 1999	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as TAMOXIFEN (DIN 02237597) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Oct 25, 2016	Sep 28, 1999	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as PMS-TAMOXIFEN (DIN 02237459) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Oct 28, 2016	Dec 1, 1998	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as PMS-TAMOXIFEN (DIN 02237460) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Oct 28, 2016	Dec 1, 1998	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as TAMONE - (20 MG) (DIN 02063751) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Oct 2, 2007	Dec 31, 1996	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as TAMONE - (10 MG) (DIN 02063778) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Oct 2, 2007	Dec 31, 1996	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as NOLVADEX-D TAB 20MG (DIN 02048485) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Mar 22, 2023	Dec 31, 1995	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as MYLAN-TAMOXIFEN (DIN 02089858) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Jan 9, 2017	Dec 31, 1994	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as MYLAN-TAMOXIFEN (DIN 02088428) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Jan 9, 2017	Dec 31, 1994	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as NOLVADEX TAB 10MG (DIN 02048477) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Apr 1, 2003	Dec 31, 1994	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as TAMOPLEX TAB 10MG (DIN 01951939) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Sep 9, 1996	Dec 31, 1992	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as TAMOPLEX TAB 20MG (DIN 01951947) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Sep 9, 1996	Dec 31, 1992	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as TEVA-TAMOXIFEN (DIN 00851965) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Dec 31, 1990	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as TEVA-TAMOXIFEN (DIN 00851973) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Dec 31, 1990	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as APO-TAMOX TAB 10MG (DIN 00812404) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Dec 31, 1989	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as TAMONE TAB 10MG (DIN 00810444) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Sep 10, 1996	Dec 31, 1989	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as APO-TAMOX TAB 20MG (DIN 00812390) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Dec 31, 1989	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as TAMONE TAB 20MG (DIN 00810452) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Sep 10, 1996	Dec 31, 1989	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as TAMOFEN 10 (DIN 01926624) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Jan 11, 2011	Dec 31, 1986	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as TAMOFEN 20 (DIN 01926632) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Jan 14, 2011	Dec 31, 1986	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as DOM-TAMOXIFEN (DIN 02237598) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Oct 25, 2016	—	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as PENTA-TAMOXIFEN TABLETS (DIN 02232551) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled (Unreturned Annual)since Apr 5, 2018	—	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as DOM-TAMOXIFEN (DIN 02237599) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Oct 25, 2016	—	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as PENTA-TAMOXIFEN TABLETS (DIN 02232552) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled (Unreturned Annual)since Apr 5, 2018	—	health-canada-dpd
Vorinostat	CA Health Canada	—	Marketed in Canada as ZOLINZA (DIN 02327619) under ATC L01XH01 VORINOSTAT. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jun 29, 2009	health-canada-dpd